Lizam 10mg/5mg Tablets
Package leaflet: Information for the user
Lizam 10 mg/5mg tablets Lizam 20 mg/10mg tablets Lizam 20 mg/5mg tablets Lisinopril/Amlodipine
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Lizam is and what it is used for
2. What you need to know before you take Lizam
3. How to take Lizam
4. Possible side effects
5. How to store Lizam
6. Contents of the pack and other information
1. What Lizam is and what it is used for
Lizam tablet is a combination product of amlodipine, which belongs to a group of medicines called calcium channel blockers, and lisinopril, which belongs to a group of medicines called angiotensinconverting enzyme (ACE) inhibitors. Lizam is used to treat hypertension (high blood pressure) in adults.
Lizam 10 mg/5mg tablet is indicated in adult patients whose blood pressure has already been controlled on the combination of 10 mg lisinopril and 5 mg amlodipine.
Lizam 20 mg/10mg tablet is indicated in adult patients whose blood pressure has already been controlled on the combination of 20 mg lisinopril and 10 mg amlodipine.
Lizam 20 mg/5mg tablet is indicated in adult patients whose blood pressure has already been controlled on the combination of 20 mg lisinopril and 5 mg amlodipine.
In patients with high blood pressure amlodipine works by relaxing blood vessels, so that blood passes through them more easily. It also improves blood supply to the heart muscles. Lisinopril decreases the tightness of your blood vessels and lowers your blood pressure.
You might not have any symptoms from your too high blood pressure, but it may increase the risk of certain complications (such as stroke or heart attack), if you do not take your antihypertensive medicine regularly.
2. What you need to know before you take Lizam
Do not take Lizam
You must not take this medicine:
- if you are allergic to the lisinopril or the amlodipine or any of the other ingredients of this medicine (listed in section 6)
- if you are allergic to other ACE inhibitors (such as enalapril, captopril and ramipril) or other calcium channel blockers (such as nifedipine, felodipine or nimodipine)
- if you have had an angioedema (severe allergic reaction, symptoms such as itching, nettle rash,
wheezing and swelling of the hands, throat, mouth or eyelids), related or not to treatment with an ACE-inhibitor
- if a family member has ever had a severe allergic reaction (hereditary angioedema) or if you have earlier had a severe allergic reaction of an unknown cause (idiopathic angioedema).
- if your blood pressure is too low (severe hypotension)
- if you have a narrowing of the aorta (aortic stenosis), of a heart valve (mitral stenosis), an increase in the thickness of the heart muscle (hypertrophic cardiomyopathy)
- if you have circulatory failure (including shock originating in the heart called cardiogenic shock).
- if you have suffered a heart attack (myocardial infarction) with heart failure
- If you are more than 3 months pregnant. (It is also better to avoid {(Invented) name} in early pregnancy - see pregnancy section.)
- if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
Warnings and precautions
You must tell your doctor if you think you are (or might become) pregnant. {(Invented) name} is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).
Talk to your doctor before taking Lizam if you:
- have heart problems
- have problems with your blood vessels (collagen vascular disease)
- have kidney problems
- have liver problems
- are undergoing a surgery (including dental surgery) or anaesthesia
- are under dialysis
- are about to have a treatment called LDL apheresis for removal of cholesterol
- are older than 65 years
if you are on a low-salt diet and you use potassium containing salt substitutes or supplements or have high levels of potassium in your blood (hyperkalaemia)
- have diabetes mellitus
- have diarrhoea or vomiting
- desensitisation treatment to reduce allergy to bee or wasp stings
- if you are of black origin as ACE inhibitors may be less effective, but you may also more readily get angioedema
- if you are taking any of the following medicines used to treat high blood pressure:
• an “angiotensin II receptor blocker” (ARBs) (also known as sartans - for example valsartan, telmisartan, irbesartan), in particular if you have diabetes-related kidney problems
• aliskiren
- are taking any medicines listed below
Talk to your doctor if you develop a dry cough which is persistent for a long time after starting treatment with Lizam.
Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.
See also information under the heading “Do not take Lizam”.
Children and adolescents
Lizam should not be used in children below age 18.
Other medicines and Lizam
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
Potassium-sparing diuretics (such as spironolactone, amiloride, triamterene, used to reduce fluid retention) and potassium supplements or potassium containing salt substitutes may only be taken together with Lizam under close medical supervision.
Special caution is necessary when Lizam is taken together with the following medicines:
- water tablets called diuretics (used to reduce fluid retention)
- other medicines used to lower blood pressure (antihypertensives)
- medicines used in the treatment of heart diseases (e.g. verapamil, diltiazem)
- non-steroidal anti-inflammatory drugs (NSAIDs) such as acetylsalicylic acid (used to treat for arthritis, muscle pains, headache, inflammation, fever)
- lithium, tricyclic antidepressants, antipsychotics, used to treat mental disorders
- insulin and oral antidiabetics
- autonomous nervous system stimulants (sympathomimetics), such as ephedrine, phenylephrine, xylometazoline and salbutamol, used to treat congestion, cough, cold and asthma
- immunosuppressants (used to prevent transplant rejection, e.g. corticosteroids, cytotoxic agents and antimetabolites)
- allupurinol, used to treat gout
- procainamide (used in arrhythmias)
- heparin (to treat blood clots)
- simvastatin (to lower cholesterol and certain fatty substances in your blood)
- narcotics, morphine and related drugs used to treat severe pain
- anticancer drugs
- anaesthetics, used in surgery or some dental procedures. Tell your doctor or dentist that you are taking {(Invented) name} before you are given a local or general anaesthetic, given the risk of short-term drop in blood pressure
- anticonvulsants (such as carbamazepine, phenobarbital and phenytoin), used to treat epilepsy
- medicines used to treat bacterial (antibiotics e.g. rifampicin, erythromycin or clarithromycin), HIV (so called protease inhibitors e.g. ritonavir, indinavir, nelfinavir) or fungal infections (e.g. ketoconazole, itraconazole)
- herbal preparations containing St. John's wort (Hypericum perforatum)
- gold salts, especially when given intravenously (used to treat the symptoms of rheumatoid arthritis)
- dantrolene (skeletal muscle relaxant, used to treat malignant hyperthermia)
Your doctor may need to change your dose and/or to take other precautions:
- If you are taking an angiotensin II receptor blocker (ARB) or aliskiren (see also information under the headings “Do not take Lizam” and “Warnings and precautions”).
Lizam with food, drink and alcohol
Lizam can be taken with or without food, but alcohol should be avoided during treatment.
Grapefruit juice and grapefruit should not be consumed by people who are taking Lizam. This is because grapefruit and grapefruit juice can lead to an increase in the blood levels of the active ingredient amlodipine, which can cause an unpredictable increase in the blood pressure lowering effect of Lizam.
Pregnancy, breast-feeding and fertility
Pregnancy
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Lizam before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Lizam. Lizam is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Breastfeeding
Tell your doctor if you are breast-feeding or about to start breast-feeding Lizam is not recommended
for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.
Driving and using machines
Before you drive a vehicle, use tools or operate machines, or carry out other activities that require concentration, make sure you know how Lizam affects you. Lizam can affect your ability to drive and use machinery safely (especially at the start of the treatment). Do not drive or use machines if you notice that Lizam negatively affects your ability to drive or operate machines, e.g. make you feel sick, dizzy or tired, or give you a headache.
3. How to take Lizam
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is 1 tablet Lizam daily. Lizam can be taken with or without food. Swallow each tablet whole with a drink of water. You should take your tablet at the same time each day.
If you have the impression that the effect of Lizam is too strong or too weak, talk to your doctor or pharmacist.
Use in children and adolescents
Lizam should not be used in children below age 18 due to lack of data on safety and efficacy.
Elderly
Generally no special dosage modification is necessary above the age of 65.
Patients with liver impairment
A liver disease can influence the blood level of amlodipine. In this case your doctor will advise you more frequent medical checking.
Patients with kidney impairment
Your regular medical follow-up will include frequent monitoring of renal function, serum potassium and sodium levels during therapy with Lizam. In case of worsening of the kidney function Lizam will be withdrawn and replaced by the therapy with individual components adequately adjusted.
If you take more Lizam than you should
Contact your doctor immediately or go to the casualty department of the nearest hospital.
Overdose is likely to result in very low blood pressure, which has to be closely monitored. Signs of an overdose are electrolyte imbalance, kidney failure, rapid breathing (hyperventilation), a fast heart rate, palpitations, a slow heart beat, dizziness, anxiety, cough.
You may feel lightheaded, faint or weak. If blood pressure drop is severe enough shock can occur. Your skin could feel cool and clammy and you could lose consciousness. If characteristic symptoms such as dizziness and headache occur, you should be placed lying down with the face up. Your doctor will take further measures.
If you forget to take Lizam
Do not take a double dose to make up for a forgotten tablet, to avoid the risk of overdose. Take your next dose at the usual time.
If you stop taking Lizam
Keep taking your tablets until your doctor tells you to stop. If you feel better, do not stop taking the tablets. If you stop them, your conditions may get worse.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible side effects
4.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common side effects (may affect up to 1 in 10 people)
in a clinical trial with amlodipine and lisinopril combination were: headache, cough, dizziness, palpitations (a quicker or irregular heart beat), and pruritus.
Allergic (hypersensitivity) reactions may occur with the use of Lizam. You must stop taking Lizam and seek medical attention immediately if you develop any of the following symptoms of angioedema:
- difficulty in breathing with or without swelling of the face, lips, tongue and/or throat.
- swelling of the face, lips, tongue and/or throat which may cause difficulty in swallowing.
- severe itching of the skin (with raised lumps).
Additional side effects that have been reported with either amlodipine or lisinopril alone (the two active substances), and may also occur with Lizam are the following:
Amlodipine
Common side effects (may affect up to 1 in 10 people):
Headache, oedema (for example ankle swelling), feeling tired, sleepiness, feeling sick, dizziness, abdominal pain, palpitations (a quicker or irregular heart beat), nausea, flushing.
Tell your doctor if these effects cause you any problems or if they last for more than one week.
Uncommon side effects (may affect up to 1 in 100people):
Skin rash, itchy skin, loss of hair, red patches on skin, skin discolouration, indigestion, vomiting (being sick), muscle cramps, altered bowel habit (diarrhoea and constipation), muscle or joint pain, back pain, chest pain, mood changes (including anxiety), depression, sleeplessness, shaking, visual disturbances, tinnitus (ringing in the ear), hypotension (low blood pressure), difficulty in breathing, taste perversion, paraesthesia (numbness or tingling sensation), runny nose, frequent need to urinate at night, urination disorders, dry mouth loss of pain sensation, increased sweating, fainting, pain, malaise (feeling unwell), weakness, enlargement of breasts in men, impotence, weight increase, weight decrease.
Rare side effects (may affect up to 1 in 1000people):
Confusion.
Very rare side effects (may affect up to 1 in 10 000 people):
Allergic reactions, abnormal liver function test, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), decrease in the number of white blood cells and platelets in the blood, elevation of blood glucose, heart attack (myocardial infarction), irregular heartbeat (arrhythmia), cough, severe skin reactions, (nettle rash, scaly or peeling skin, severe allergic reactions accompanied with fever, red patches, joint pains and/or eye disorders (Stevens-Johnson syndrome), swelling of the lips, eyelids and genitals (Quincke's oedema)), swelling or soreness of the gums, inflammation of the pancreas (pancreatitis), inflammation of the lining of the stomach (gastritis), hives, sensitivity to light, hypertonia (increased muscle tension), peripheral neuropathy (nerve disorder causing weakness and tingling sensation), inflammation of blood vessels.
Lisinopril
Common side effects (may affect up to 1 in 10 people)
Headache, dizziness or light-headedness especially when standing up quickly, diarrhoea, cough, vomiting, kidney problems.
Uncommon side effects (may affect up to 1 in 100 people)
Mood changes, change of colour (pale blue followed by redness) and/or numbness or tingling in the
fingers or toes (Raynaud phenomenon), changes in the way things taste, fatigue, feeling sleepy or difficulty in going to sleep, strange dreams, spinning feeling (vertigo), abnormal skin sensations (as tingling or tickling or itching or burning), feeling of rapid and irregular heartbeat (palpitation), heart attack (myocardial infarction), stroke, runny nose, nausea (feeling sick), stomach pain or indigestion, impotence, tiredness, changes in the results of certain laboratory tests (that show how your kidney and liver are working), skin rash, itching, rapid heartbeat (tachycardia).
Rare side effects (may affect up to 1 in 1000people):
Angioedema (hypersensitivity reaction with sudden swelling of the lips, face and neck, and occasionally of the feet and hands; there is a higher rate of angioedema in black patients than in nonblack patients). Confusion, inappropriate secretion of the antidiuretic hormone, which controls the amount of urine you excreate, acute kidney problems, kidney failure, dry mouth, hair loss, psoriasis, hives, enlargement of breasts in men.
Worsening of blood picture: decrease in haemoglobin and haematocrit levels. Increase in bilirubin level (bile pigment), low level of sodium in the blood.
Very rare side effects (may affect up to 1 in 10 000people):
Decrease of blood glucose (hypoglycaemia), sinus pain wheezing, inflammation of the lungs (pneumonia), yellow skin and/or eyes (jaundice), inflammation of the liver or pancreas, liver failure, severe skin disorders (symptoms of which include redness, blistering and peeling), sweating.
Reduction of urine volume (passing less water (urine) or passing no water). Oedema in the bowels. Worsening of blood count: decrease in the number of red blood cells (anaemia). Worsening of blood picture: decrease in the number of platelets in the blood (thrombocytopenia), decrease in the number of white blood cells (neutropenia, leucopenia, agranulocytosis). These problems may cause prolonged bleeding, tiredness, weakness, disease of the lymph nodes, autoimmune disorder (when your immune system produces antibodies against your own tissues). You can get infections more easily.
Not known (frequency cannot be estimated from the available data)
Fainting, depression.
If you get any side effects talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Lizam
Store below 25°C.
Store in the original package in order to protect from light and moisture.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blisters and the carton after ‘Exp’. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Lizam contains
- The active substances are lisinopril and amlodipine.
Lizam 10 mg/5mg tablets:
Each tablet contains 10 mg lisinopril (as dihydrate) and 5 mg amlodipine (as besilate).
Lizam 20 mg/10mg tablets:
Each tablet contains 20 mg lisinopril (as dihydrate) and 10 mg amlodipine (as besilate).
Lizam 20 mg/5mg tablets:
Each tablet contains 20 mg lisinopril (as dihydrate) and 5 mg amlodipine (as besilate).
- The other ingredients are microcrystalline cellulose, sodium starch glycolate (type A) and magnesium stearate.
What Lizam looks like and contents of the pack
Lizam 10 mg/5mg tablets:
White or almost white, round, flat, bevel-edged tablet with a score line on one side and with an engraving “A+L” on the other side, diameter approx. 8 mm.
The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
Packs contain 30 or 90 tablets in white, PVC/PE/PVDC-aluminium blisters in a carton.
Not all pack sizes may be marketed.
Lizam 20 ms/10ms tablets:
White or almost white, round, biconvex tablet with engraving on one side: “CF3”, other side without engraving. Diameter approx. 11 mm.
Packs contain 30 or 90 tablets in white, PVC/PE/PVDC-aluminium blisters in a carton.
Not all pack sizes may be marketed.
Lizam 20 mg/5 mg tablets:
White or almost white, round, biconvex tablet with engraving on one side: “CF2”, other side is without engraving. Diameter 11 mm.
Packs contain 28, 30, 50, 56, 90, 98 or 100 tablets in white, PVC/PE/PVDC-aluminium blisters in a carton.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Gedeon Richter Plc.
Gyomroi ut 19-21,
H-1103 Budapest Hungary
Manufacturer:
Gedeon Richter Plc.
Gyomroi ut 19-21,
H-1103 Budapest Hungary
This medicinal product is authorised in the Member States of the EEA under the following names:
United Kingdom: Lizam
This leaflet was last revised in January 2015.
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